Senior Design Quality Engineer
Smith+Nephew · Mansfield, MA
- Level
- Senior
- Team
- Quality
- Base pay
- $97k–$120k
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
A senior quality role at Smith+Nephew (medical devices) in Mansfield, MA. You will play a critical role in supporting the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring they remain safe, effective, compliant, and aligned with the needs of both patients and healthcare professionals.
- They ask for
- 5+ years · degree required
- Tools it names
- Six Sigma, Root cause, FMEA, CAPA, ISO 13485, FDA / GMP
- Base pay
- $97k–$120k
- Day to day
- some off-shift / weekend coverage
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- 1
Pick 2–3 people on the Quality team at Smith+Nephew
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About the role
requirements
- ✓Partner closely with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality teams to support regulatory submissions, audits, inspections, and ongoing product support
- ✓Act as a quality engineering resource for complex technical and compliance related issues, providing guidance and influencing decisions that impact product quality, patient safety, and business objectives
- ✓Identify and drive continuous improvement opportunities through analysis of quality data, product feedback, risk management outputs, and operational performance metrics
- ✓Provide technical leadership, training, guidance, and mentorship to support effective decision making, accountability, compliance, and quality excellence
What will you need to be successful?
- ✓Bachelor of Science degree in Engineering or a technically related field
- ✓5+ years of experience in the medical device industry or another highly regulated environment
- ✓Strong knowledge of FDA QSR, ISO 13485, and ISO 14971
requirements
- ✓Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management
- ✓Demonstrated ability to solve complex quality challenges and influence cross functional stakeholders
- ✓Excellent communication, collaboration, and problem solving skills
- ✓CQE and/or Six Sigma certification preferred
You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement. Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day. Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program. Flexibility: Hybrid Work Model (for most professional roles). Training: Hands On, Team Customized, Mentorship. Extra Perks: Discounts on fitness clubs, travel and more!
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Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Do you thrive in a collaborative environment where innovation, quality, and patient safety are at the heart of everything you do? As a Senior Design Quality Engineer, you will play a critical role in supporting the sustaining and lifecycle management of Sports Medicine Joint Repair products, ensuring they remain safe, effective, compliant, and aligned with the needs of both patients and healthcare professionals. Based in Mansfield, MA, this is an opportunity to influence product quality, drive continuous improvement, and partner with cross functional teams to make a meaningful impact.
What will you be doing?
- •Serve as the Design Quality representative for product support and lifecycle management activities, including product improvements, design changes, quality planning, investigations, and continuous quality enhancement initiatives
- •Lead risk management activities including risk assessments, FMEA development and maintenance, implementation of risk controls, risk reviews, and verification of effectiveness
- •Provide design quality oversight and approval for design verification and validation activities, sterilization validations, process validations, supplier qualifications, manufacturing process changes, and test methods
- •Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments to identify root causes and drive corrective and preventive actions
- •Review and approve quality and engineering documentation to ensure compliance with design controls, change control, risk management, and quality system